Cleared Traditional

K150039 - MicroScan Dried Gram Positive MIC/Combo...

K150039 is an FDA 510(k) clearance for MicroScan Dried Gram Positive MIC/Combo..., manufactured by Siemens Healthcare Diagnostics, Inc.. The device is a Class 2 Microbiology device with product code LTT cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K150039 · Siemens Healthcare Diagnostics, Inc. · Microbiology device
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Jul 2015
Decision
174d
Days
Class 2
Risk

K150039 is an FDA 510(k) clearance for the MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL). Classified as Panels, Test, Susceptibility, Antimicrobial (product code LTT), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (West Sacramento, US). The FDA issued a Cleared decision on July 2, 2015 after a review of 174 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Healthcare Diagnostics, Inc. devices

FDA 510(k) Submission Details - K150039

510(k) Number K150039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2015
Decision Date July 02, 2015
Days to Decision 174 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 102d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LTT Device Classification - Class 2, Special Controls

Product Code LTT Panels, Test, Susceptibility, Antimicrobial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - LTT Panels, Test, Susceptibility, Antimicrobial

All 45
Devices cleared under the same product code (LTT) and FDA review panel - the closest regulatory comparables to K150039.
MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 – 8 µg/mL)
K172912 · Beckman Coulter, Inc. · Dec 2017
MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL)
K172255 · Beckman Coulter, Inc. · Dec 2017
MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)
K162740 · Beckman Coulter, Inc. · Mar 2017
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE
K123933 · Siemens Healthcare Diagnostics, Inc. · Mar 2013
MICROSCAN MICROSTEP
K111394 · Siemens Healthcare Diagnostics, Inc. · Jun 2011
MICROSCAN MICROSTREP PLUS, MODEL B1027-201
K091949 · Siemens Healthcare Diagnostics · Jan 2010